Important Patient Information

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

USES: This medication is used to prevent and treat seasonal and year-round allergy symptoms of the nose (stuffiness or congestion, runny nose, itching, and sneezing). It is also used to treat growths in the nose (nasal polyps). Mometasone works by reducing swelling of the nasal passages. It belongs to the class of drugs known as corticosteroids. This medication does not work immediately. It may take several weeks or longer before the full benefit of this drug takes effect. Therefore, when using mometasone to prevent seasonal allergy symptoms, start this medication 2-4 weeks before pollen season begins.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using mometasone and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. This medication is for use in the nose, usually once a day or as directed by your doctor. Avoid spraying this medication in your eyes. Gently blow your nose before using this drug. Shake the container well before each use. Follow the instructions to learn how to properly prime the spray pump if you are using it for the first time, and to learn when you need to reprime it if you have not used it regularly. To use the spray, remove the protective cap and insert the applicator tip into your nostril. Close the other nostril by pressing with your finger, and tilt your head forward slightly. Press down firmly on the pump to deliver the prescribed number of sprays. Do not spray directly onto the middle wall of your nose (the septum). Breathe in gently through your nose and out through your mouth. Repeat in the other nostril. Wipe the applicator tip and replace the protective cap. The dosage is based on your medical condition and response to therapy. Younger children require a smaller dose and need help from an adult to use this medication. Use this drug regularly during the prescribed treatment period for full benefit. Remember to use it at the same time(s) each day. Do not use this drug more often, increase your dose, or use it for longer than prescribed. Keep track of the number of sprays used from the container. Discard the container after you have used the number of sprays specified on the manufacturer's package. Inform your doctor if your symptoms do not improve or if they worsen.

SIDE EFFECTS: See also Precautions. Headache, sore throat, blood-tinged mucus/phlegm, burning/irritation/dryness of the nose, and nosebleeds may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: pain in your nose, repeated nosebleeds, whistling sound while breathing, vision changes, white patches in your nose/mouth, painful/trouble swallowing. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using mometasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: tuberculosis, untreated infections, herpes eye infection, recent nose problems (e.g., nasal septum ulcers/surgery/trauma), certain eye conditions (cataracts, glaucoma). Avoid exposure to chickenpox or measles infection while using this medication and other corticosteroids. If you are exposed to these infections, seek immediate medical attention. Though very unlikely, it is possible this medication will be absorbed into your bloodstream. This may have undesirable consequences that may require additional corticosteroid treatment. This is especially true for children and for those who have used this drug for an extended period of time and if they also have serious medical problems such as serious infections, injuries or surgeries. This precaution applies for up to one year after stopping use of this drug. Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst or urination, unusual weakness or weight loss, dizziness. Consult your doctor or pharmacist for more details, and inform them that you use (or have used) this medication. Caution is advised when using this drug in children. Though it is unlikely to occur with intranasal steroids (mometasone), this medication may temporarily slow down a child's rate of growth, but it will probably not affect final adult height. Monitor your child's height periodically. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: natalizumab, other corticosteroids (e.g., dexamethasone, prednisone). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the US product at room temperature (77 degrees F or 25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Store the Canadian product between 36 and 77 degrees F (2 and 25 degrees C). Store the medication away from light. Do not store in the bathroom. Do not freeze. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.